| CTRI Number |
CTRI/2024/01/061938 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Body Image, Psychological Distress, Risk for Eating Disorders, College going Students. |
|
Scientific Title of Study
|
Body Image and its Relation with Psychological Distress and risk for Eating Disorders among College Going Students of Golaghat, Assam |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abhilasha Saikia |
| Designation |
M.Phil Trainee |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health |
| Address |
Department of Psychiatric Social Work, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Kalibari Main Road, Tezpur, Assam
Sonitpur
ASSAM
784001
India |
| Phone |
7002234495 |
| Fax |
|
| Email |
abhilashasaikia42@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indrajeet Banerjee |
| Designation |
Assistant Professor |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health |
| Address |
Department of Psychiatric Social Work, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Kalibari Main Road, Tezpur, Assam
Sonitpur
ASSAM
784001
India |
| Phone |
9435704216 |
| Fax |
|
| Email |
indraj2015@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indrajeet Banerjee |
| Designation |
Assistant Professor |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health |
| Address |
Department of Psychiatric Social Work, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Kalibari Main Road, Tezpur, Assam
Sonitpur
ASSAM
784001
India |
| Phone |
9435704216 |
| Fax |
|
| Email |
indraj2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur, Assam, 784001 |
|
|
Primary Sponsor
|
| Name |
Abhilasha Saikia |
| Address |
Department of Psychiatric Social Work, Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Kalibari Main Road, Tezpur, Assam |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Indrajeet Banerjee |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health |
Department of Psychiatric Social Work, LGBRIMH, 4th floor,Tezpur, Sonitpur, Assam,
Sonitpur
ASSAM |
9435704216
indraj2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
College going students |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
22.00 Year(s) |
| Gender |
Both |
| Details |
1. Those who are willing to give written informed consent.
2. Those participants, who are able to read, write and understand English language
|
|
| ExclusionCriteria |
| Details |
• Those students who are not available at the time of distributing the questionnaire will be
excluded from the study.
• Those who report of having any kind of psychiatric and physical illness.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study will help to assess & understand body image & its relation psychological distress and risk for developing eating disorder. This will further contribute to make intervention plan and will pave way for further research |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Body image is a person’s impression of their physical self and the ideas as well as feelings associated with those perceptions. It is crucial to realize that these emotions which can be either positive, negative, or a combination of the two, are influenced by both personal and environmental circumstances. College-going students are one of the vulnerable segments who are prone to compare their body structure with that of someone who they admire. the portrayal of the body structure by social media and TV has distorted a person’s perception of their body. The research sought to answer the following questions 1) What is the concern about body image among college-going students? 2) What is the risk for eating disorders and psychological distresses among college-going students? 3) Is there any association among the selected socio-demographic variables, body image, psychological distress, and risk for eating disorders among college-going students? The participants of the study will be college-going students of the selected college i.e. Debraj Roy College, Golaghat, Assam. A quantitative approach will be used with a cross-sectional descriptive research design. The total number of students in the undergraduate course of the selected college is 1365. The rao soft sample size calculator was used to calculate the total sample and it yield a total of 300 sample. The total enumeration method will be used keeping in mind the attrition rate and missing data and final year undergraduate students will be selected purposively and based on convenience. There are a total of 442 students in the final year undergraduate course for the academic year 2022 to 2024. Those participants who will meet the inclusion criteria will be taken for the study. The following tools will be administered: Socio-demographic profile sheet, Body Shape Questionnaire, Eating Attitudes Test, and Depression Anxiety Stress Scale. |